NCT06930365 Clinical-Instrumental Study To Evaluate And Compare The Efficacy And Tolerability Of Two Emollients Products In Atopic Dermatitis
| NCT ID | NCT06930365 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NAOS Les Laboratoires |
| Condition | Atopic Dermatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2024-12-09 |
| Primary Completion | 2025-05-16 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
Atopic dermatitis (AD) is a chronic inflammatory skin disease associated with erythema, scaly and oozing plaques, and severe pruritus which has an important impact on quality of life and quality of sleep. It is divided into 2 chronic phases : flare-up and remission period. Signs and symptoms of AD are associated with a compromised immune system, a defective skin barrier, a cutaneous dysbiosis and overall inflammatory status. The aim of the study is to evaluate and compare the efficacy and tolerability of two face and body cream products, new emollient versus placebo, in used over the course of 5 weeks as a replacement of usual or any emollient by female and male subjects with atopic dermatitis. This is an interventional, single-center, double-blind, randomized and comparative study.
Eligibility Criteria
Inclusion Criteria: * Female and/or male participants, * Participant aged between 18 years old and more included, * All ethnicities * Phototype II to IV * Participant with all skin types, sensitive or not sensitive, * 44 subjects having a rash of eczema (SCORAD between 25 and 50) with at least 1 lesional area requiring topical corticosteroid treatment, * 22 healthy subjects (without any dermatological pathology nor disorder), * 44 participants having whitened eczema lesions at Dx (between 5 to 10 days) after the topical corticosteroid treatment, * Participants having signed their written Informed Consent form (ICF) for their participation in the study and a photograph authorization, * Participant able to comply with the protocol and follow protocol's constraints and specific requirements. Exclusion Criteria: * Participant does not meet the inclusion criteria, * Known pregnancy, participant breastfeeding, or not willing to take necessary precautions to avoid a pregnancy during the study
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